MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® 9NC 0.109M BUFFERED TRISODIUM CITRATE PLUS BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	363047
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported when using the bd vacutainer® 9nc 0.109m buffered trisodium citrate plus blood collection tubes, the device experienced clotting / micro clots/fibrin clots.This event occurred two times.The following information was provided by the initial reporter.The customer stated: we had 2x a problem with the pediatric citrate tubes lot 1085027 dp: 09/2021 we took from 2 children the platelet aggregation on them and the laboratory assistants came back to us, specifying that the blood was coagulated.
Additional Manufacturer Narrative
H6: investigation summary: bd received 237 samples for investigation.The customer samples were evaluated along with retention samples of the incident lot selected from bd inventory.The samples were tested and no issues relating to clotting were observed.All tubes filled as expected and all results were normal.Analytical testing and visual inspection of the retained and control tubes did not confirm the reported defects.Bd was unable to confirm the customers¿ indicated failure, clotting, because the defect was not evident in the testing of the retained lot samples.Visual evaluations of both retain and control samples for clotting demonstrated clinically acceptable performance.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint is unable to be confirmed for the indicated failure mode clotting.Bd was not able to identify a root cause for the indicated failure mode.
Event or Problem Description
It was reported when using the bd vacutainer® 9nc 0.109m buffered trisodium citrate plus blood collection tubes, the device experienced clotting / micro clots/fibrin clots.This event occurred two times.The following information was provided by the initial reporter.The customer stated: we had 2x a problem with the pediatric citrate tubes lot 1085027 dp: (b)(6) 2021.We took from 2 children the platelet aggregation on them and the laboratory assistants came back to us, specifying that the blood was coagulated.

• Brand Name: BD VACUTAINER® 9NC 0.109M BUFFERED TRISODIUM CITRATE PLUS BLOOD COLLECTION TUBES
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12380239
• Report Number: 9617032-2021-00923
• Device Sequence Number: 4116226
• Product Code: JKA
• UDI-Device Identifier: 50382903630474
• UDI-Public: 50382903630474
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K013971
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 09/30/2021
• Device Model Number: 363047
• Device Catalogue Number: 363047
• Device Lot Number: 1085027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2021
• Supplement Date Received by Manufacturer: 12/08/2021
• Initial Report FDA Received Date: 08/27/2021
• Supplement Report FDA Received Date: 12/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/26/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown